203 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Canada
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GluStitch Inc.
Manufacturer
🇨🇦 Canada·1 Basic UDI-DI·3 Devices·2 Importers
I3 BioMedical Inc.
Manufacturer
🇨🇦 Canada
Coroneo Inc.
Manufacturer
🇨🇦 Canada·49 Basic UDI-DIs·49 Devices·2 Importers·GMED SAS and GMED SAS
Panthera Dental Inc.
Manufacturer
🇨🇦 Canada
Vielight Inc.
Manufacturer
🇨🇦 Canada
DMF Medical Inc
Manufacturer
🇨🇦 Canada
MetaOptima Technology Inc.
Manufacturer
🇨🇦 Canada·1 Importer
Innovere Medical Inc.
Manufacturer
🇨🇦 Canada·2 Importers
Kent Imaging Inc.
Manufacturer
🇨🇦 Canada
Labex Canada Inc.
Manufacturer
🇨🇦 Canada·1 Importer
DNA Genotek Inc.
Manufacturer
🇨🇦 Canada·10 Basic UDI-DIs·31 Devices·5 Importers
Nuraleve
Manufacturer
🇨🇦 Canada·2 Basic UDI-DIs·2 Devices·BSI Group The Netherlands B.V.
Meditech International Inc
Manufacturer
🇨🇦 Canada·18 Basic UDI-DIs·18 Devices·1 Importer·GMED SAS
GenomeMe Lab Inc.
Manufacturer
🇨🇦 Canada·2 Importers
Microbix Biosystems Inc.
Manufacturer
🇨🇦 Canada·1 Importer
Brand Name: Novasight Hybrid System Product Name: Novasight Hybrid Catheter Model/Catalog Number: TA-06-0001 Product Description: Common Name: Diagnostic intravascular catheter Description: The Novasight Hybrid catheter is a 3Fr single use, sterile device, which will be able to perform transluminal ultrasound and optical coherence tomography imaging of adults. The catheter is capable of real-time 2D side viewing ultrasound and optical imaging acquired simultaneously providing precisely co-registered images with the ability to produce rapidly post processed rendered longitudinal images of the vessel. Packaging: The Novasight Hybrid Catheter is packaged in a packaging system including the protective packaging and the sterile barrier system.
FDA Enforcement
Class I
·Ongoing·Conavi Medical Inc.·April 30, 2025
PeriAcryl®90 HV Cyanoacrylate Oral Adhesive
Device
EU MDR
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Eu Md Class 1
·GluStitch Inc.·On the market·13 countries
PeriAcryl®90
Device
EU MDR
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Eu Md Class 1
·GluStitch Inc.·On the market·13 countries
PeriAcryl®90
Device
EU MDR
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Eu Md Class 1
·GluStitch Inc.·On the market·13 countries
THORACIC SURGERY INSTRUMENTS, REUSABLE - OTHER
Device
EU MDD
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Eu Md Class 2a
·Coroneo Inc.·On the market·5 countries